sing magnetic resonance spectroscopy (MRS) to identify breast cancer patients who early respond to chemotherapy (after the first chemotherapy cycle) before breast cancer surgery.

• Conditions: Early breast cancer requiring neoadjuvant chimiotherapy; MedDRA version: 14.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006259-12-BE
• Lead Sponsor: Jules Bordet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-23
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Female gender
2. Age = 18 years
3. Signed written consent prior to any study specific screening procedures
4. Performance status - Eastern Cooperative Oncology Group (ECOG) 0-1
5. Previously untreated invasive ductal or lobular locally advanced breast cancer or any breast cancer = 2 cm, radiologically measured by breast MRI, with an indication for neoadjuvant chemotherapy;
6. Know receptor status (ER, PgR) HER2 overexpression and Ki67 index defined by local policy.
7. Adequate organ function including:
neutrophils = 1.5 x 109 /L
platelets = 100 x 109 /L
haemoglobin = 10 g/dL
bilirubin = 1.25 x upper limit of normal (ULN)
Transaminasas: aspartate aminotransferase (AST) = 2.5 x ULN, amino alanine transferase (ALT) = 2.5 x ULN and alkaline phosphate (ALP) = 2.5 x ULN
serum creatinine = 1.5 x ULN
8. Baseline left ventricular ejection fraction (LVEF) must be measured within 14 days prior to day 1 of the first anthracyclines cycle and must be = 50%
9. Negative serum pregnancy test, done within 14 days prior to day 1 of the first anthracyclines cycle (for women of childbearing potential)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Subject received any prior treatment for primary invasive breast cancer
2. Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial
4. Contra-indication for MRI examination
Claustrophobia
Gadolinium hypersensivity
Severe renal failure
Medical electronic devices carriers
5. Contra-indication for anthracyclines-based chemotherapy
6. Pregnant or lactating woman

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified